At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed mixed mesodermal tumor (MMT) of the uterus with no visible residual disease after surgery
- ✓Surgical staging completed with total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node sampling
- ✓Surgical staging completed 6 weeks ± 7 days prior to enrollment
- ✓Age 18 years or older
- ✕Severe or uncontrolled medical disease including uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, or congestive heart failure
- ✕Prior chemotherapy or radiotherapy for pelvic malignancy
- ✕Myelosuppressive chemotherapy within 3 weeks prior to study entry
- ✕Uterine sarcoma other than mixed mesodermal tumor (MMT)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Phase II Trial of Adjuvant Radiation Therapy "Sandwiched" Between Ifosfamide in Patients With Mixed Mesodermal Tumors
In Brief
A Phase 2 clinical trial evaluating Ifosfamide, Radiation Therapy, and 1 other intervention for Uterine Cancer. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The optimal sequence and /or modality for adjuvant therapy in the management of Mixed Mesodermal Tumors (MMT) clearly remains to be established. The rationale for the protocol is to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis. The proposed study will sandwich radiation between the two most active chemotherapeutic agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease both local and distant recurrence, which may translate into an improved progression free interval and possibly even extend survival.
Study Details
Timeline
Interventions
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg/IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg /IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.
dosage is 20 mg/m2/day for 5 days, ever 3 weeks.